Clinical Trial: Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics
Brief Summary: The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. All subjects were monitored an additional two days following the dosing period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4, 6 and 7. We hypothesized that there would be no difference in aminotransferase means between the groups at any study period.
Detailed Summary:
Sponsor: Denver Health and Hospital Authority
Current Primary Outcome:
- group mean aminotransferase measures
- mean change in aminotransferase measures between study groups
Original Primary Outcome: Same as current
Current Secondary Outcome:
- proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range
- proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)
- proportion of subjects that develop drug induced liver injury
Original Secondary Outcome: Same as current
Information By: Denver Health and Hospital Authority
Dates:
Date Received: January 24, 2007
Date Started: November 2004
Date Completion:
Last Updated: February 6, 2009
Last Verified: February 2009
